Computer System Validation (CSV) Expert (Pharma Domain)

I am a seasoned consultant in Regulatory Compliance and Computer System Validation (CSV) holding an MSc degree. My expertise lies in the realm of technical documentation and compliance validation, encompassing various regulatory authority guidelines.

I am committed to providing comprehensive assistance to companies navigating the complexities of compliance with 21 CFR Part 11 Electronic Records and Electronic Signatures, as well as Annex 11, Computerized Systems. My focus extends to offering holistic solutions for quality management systems, encompassing various investigative processes within the pharmaceutical domain.

The process of Computer System Validation (CSV) is a pivotal aspect of our services. Widely employed in the pharmaceutical, healthcare, and other regulated industries, CSV is designed to ensure that computerized systems adhere to predefined requirements and regulatory guidelines. The primary objectives of CSV are to guarantee the reliability, integrity, and security of computer systems utilized in critical processes, such as manufacturing, laboratory testing, data analysis, and documentation.

Additionally, my RC Solutions agency functions as an all-encompassing solution provider for a wide range of web development and SEO requirements. This involves not only addressing the intricacies of mobile application development but also extending specialized services in technical and scientific content writing. Our unwavering commitment to delivering complete solutions emphasizes our dedication to fulfilling the diverse needs of our clients spanning across various domains.

Work Terms

CURRENT PROFESSIONAL EXPERIENCE

Computer Systems Validation (CSV)
• Designing and developing validation deliverables such as validation plan, user requirements and
functional specifications in the areas of materials management, production planning, quality
management, warehouse management, sales and distribution, plant maintenance, service
management etc.
• Meet/interact/coordinate with client’s ERP system implementation team and
users for walkthroughs, status updates/validation findings and for implementing and establishing
security controls.
• Perform Risk Analysis to determine the nature and severity of the potential risk of the software being validated so as appropriate actions can be taken to mitigate these risks.
• Prepare test cases and scripts corresponding to each product requirement and specifications (i.e.
Platform IQ, Application OQ, System PQ protocols).
• Executing Validation protocols, prepare deviation/incident reports on system errors and recommend resolutions.
• Develop/create the Validation Trace Matrix and Validation Summary Report. Environments Validated

TECHNICAL SKILL

Ø Maintain the quality systems such as Change Control, Deviation Control, Out of Specification, Out of Calibration, Control of Non-conforming products, CAPA, Product Quality Reviews, etc.

Ø Handling of investigations,Events, its impactassesment and route cause analysis

Ø Review of analytical reports as well as production BMRS

Ø Sound knowledge in preparation of SOP’s preparation of RM & FP specification, Quality Manual, Site Master File, Validation Master Plans,protocols and Trend Analysis of API

Ø Coordinating with various departments like production, R&D and outside customers /suppliers

Ø Handling of quality & non-quality customer/market complaints and Handling of return and rejected goods

Ø Worked as an internal auditor for various departments

Ø Involved in vendor Qualification and maintaining the tracks of vendor audits

Ø Qualification of analytic